In the five years since its founding, theAssociation for the Accreditation ofHuman Research Protection Programs(AAHRPP) has made significantinroads in advancing accreditationand raising the bar for humanresearch protections. It has establisheduniversal high standards that safe-guard the rights and welfare ofresearch participants without placingundue burden on those engaged inresearch. Equally important, it hasunited individuals, organizations, andgovernment agencies in a sharedcommitment to build a culture of con-cern and respect throughout theresearch enterprise, and to ensure thatprotections keep pace with changingresearch trends.

The seven organizations that estab-lished AAHRPP in 2001 — Associationof American Medical Colleges,Association of American Universities,

Consortium of Social ScienceAssociations, Federation of AmericanSocieties for Experimental Biology,National Association of StateUniversities and Land-Grant Colleges,National Health Council, and PublicResponsibility in Medicine andResearch — set an ambitious visionfor the new organization. It would berecognized both nationally and inter-nationally as an organization thatimproves the protections provided byresearch programs, and would be theprogram of choice for all organiza-tions that seek accreditation ofhuman research protection programs(HRPPs). Just five years later, thatvision has been realized. AAHRPP isnow the sole HRPP accrediting body inthe United States, has extended itsreach abroad, and is widely regardedas a highly effective advocate for safe,ethical research.

Five Years of Advancing Human Protections and Ethical Research

V O L U M E 3 • N U M B E R 4

4 UI and WIRB SetExample for Accreditation

5 Insights into IRBs

7 Navigating the Regulations for Exemptions

CONTINUED ON PAGE 3

WINTER 2006 / 2007

2001AAHRPP incorporated

Executive Director takes helm

Interim standardsreleased for publiccomment

2002Accreditation program launched; first applicationsaccepted

Council onAccreditation established

Site visits begin

2003First organizationsattain accreditation

2004OHRP and PhRMAannounce support foraccreditation

2005First annual accreditation conference

First SupportingMember organizationsjoin AAHRPP

VA awards accreditationcontract to AAHRPP

200639 organizations with 106 entities haveattained accreditation;380 more in process

First internationalaccreditationannounced

Reaccreditations begin

Accreditation Highlights

This year, as we mark AAHRPP’s fifthanniversary, what we’re really cele-brating is the fifth anniversary ofaccreditation. Of course, we take greatpride in our accomplishments thesepast five years, particularly in the factthat accreditation has both taken holdin the United States and has madeinroads abroad. It’s important toacknowledge, however, that theseaccomplishments do not belong toAAHRPP alone. Instead, they areshared by each organization that haschosen to undergo the voluntary —and very rigorous — accreditationprocess.

Each accreditation is a reminderthat, regardless of our different per-spectives, so many of us throughoutthe research enterprise are united in acommon mission: to protect the rightsand welfare of research participantsand promote scientifically meritoriousand ethically sound research.Together, we are building a culturethat respects the social contractbetween the research community andthe public. The terms of the contractare fairly simple. The public supportsresearch as taxpayers, participants, orboth. In return, we are accountable to them. For some, this represents afundamental change in values, but it’s a relationship that will serve thepublic and the research enterpriseextremely well, especially given forecasts for significant growth inresearch in the coming years.

This issue of AAHRPP Advance is the ideal forum in which to reflect onsome of the accomplishments sinceour founding (see Five Years ofAdvancing Human Protections andEthical Research, page 1). It alsogives us an opportunity to shine a

spotlight on the first two organizationsto earn accreditation (see UI and WIRB Set Example forAccreditation, page 4) and to wel-come our newest Supporting Member(page 3).

Because we are committed to con-tinuous quality improvement, it’s onlyfitting that we use this anniversarynot just to look back, but also to lookahead to what remains to be done.Certainly, we must continue to spreadthe word about accreditation andencourage a broad range of organiza-tions to apply, from hospitals, aca-demic institutions, and governmentagencies to clinical research organiza-tions, contract research organizations,independent review boards, privatecorporations, and research sites.Therefore, education about accredita-tion and human research protectionswill remain a key focus. A prime

example is our annual conference,which will be held February 25–27 in Baltimore, Maryland (see News &Notes, page 8). We urge as many ofyou as possible to attend.

We also encourage you to look to us — and to each other — as aresource. In keeping with that role, on page 7, we offer assistance inNavigating the Regulations forResearch Exemptions. With help

from Reese Jones, M.D., (see Insightsinto IRBs, page 5), we tackle the sensi-tive topic of responding to complaintsfrom research participants and theirfamilies.

Finally, on a more personal note,I’d like to express my appreciation toall of you who have contributed toAAHRPP’s success these first five years,from our Founding Members and

Board of Directors, to our site visi-tors, Council on Accreditation andSupporting Members, to eachorganization that has earnedaccreditation. Your vision and com-mitment are helping to transformthe research enterprise by raisingstandards, improving protections,and laying the foundation for safe,ethical research in the future.Thank you.

2 AAHRPP ADVANCE

A Common Mission and Shared Success

M A R J O R I E A . S P E E R S , Ph.D.

“Because we are committed to continuous quality

improvement, it’s only fitting that we use this anniversary

not just to look back, but also to look ahead to what

remains to be done.”

AAHRPP ADVANCE 3

AAHRPP’s Accomplishments

■ Establishing accreditation asthe gold standard. AAHRPPaccreditation is now widely regard-ed as the standard for qualityhuman research programs. To date,39 organizations with 106 entitieshave attained accreditation. Anadditional 380 — representing themajority of U.S. principal researchinstitutions — are expected to complete the accreditation processover the next several years. The Office for Human ResearchProtections and the Food and Drug Administration both includeaccreditation status in IRB registra-tions, and the Department ofEnergy research laboratories,Department of Defense facilities,and agencies within theDepartment of Health and HumanServices are seeking accreditationfor their own research programs.

■ Broad support for accredita-tion. The Institute of Medicine

Committee on Assessing the Systemfor Protecting Human ResearchParticipants, the AccreditationSubcommittee of the Secretary'sAdvisory Commission on HumanResearch Protections, and thePharmaceutical Research andManufacturers of America have allcome out in support of accredita-tion. Eleven organizations havejoined AAHRPP as SupportingMembers, promoting accreditationand encouraging those engaged inhuman research to become accred-ited. (Supporting Members are list-ed at www.aahrpp.org.)

■ The program of choice in theUnited States. In 2005, AAHRPP’sonly competitor shut its doors, cit-ing lack of interest in its accredita-tion program. At the same time,applications for AAHRPP accredita-tion were on the rise — a trend thatcontinues today. In December2005, the U.S. Department ofVeterans Affairs (VA) awarded a$4.9 million contract to AAHRPP to

provide accreditation services to VA facilities nationwide.

■ International acknowledge-ment of AAHRPP’s role expertise. Other nations increas-ingly turn to AAHRPP as the experton accreditation and humanresearch protections. Organizationsand government entities inAustralia, Canada, and India have consulted with AAHRPP onresearch protection issues. In June2006, Samsung Medical Center inSeoul, Republic of Korea, becamethe first international institution toattain accreditation.

These accomplishments signal aprofound shift within the researchcommunity: recognition that theresponsibility for protecting researchparticipants is a shared one and that voluntary self-regulation can beinstrumental in fulfilling that respon-sibility. These accomplishments alsobode well for the future, for they laythe foundation for the increasedaccountability that can restore andpreserve public confidence in research.

Five Years of Advancing Human Protections FROM PAGE 1

The Association for Public PolicyAnalysis and Management (APPAM)has joined AAHRPP as a SupportingMember both to signify APPAM’s com-mitment to safe, ethical research andto represent the concerns of thoseengaged in behavioral and social science research.

APPAM is dedicated to improvingpublic policy and management by fos-tering excellence in research, analysis,and education. Its members includeuniversities, think tanks, policyresearch organizations, and others inthe behavioral and social scienceswhose research typically is subject toIRB review.

“The vast majority of our members

conduct non-intrusive, passive studiesthat involve minimal or no risk,”explains Erik Devereux, APPAMExecutive Director. “They are deeplyconcerned that standards set by themedical community are being appliedto surveys and other social scienceresearch that present no risks whatso-ever to participants.”

He also cites concerns about theimpact of IRB review on teachingactivities, such as capstone projectsthat give students the opportunity toserve as consultants on public policyand management issues.“Increasingly, they are being told thatsuch programs are subject to IRBreview,” Mr. Devereux says.

APPAM’s decision to become aSupporting Member acknowledgesAARHPP’s long standing commitmentto attend not just to biomedicalresearch issues but also to the concernsof those in the social sciences.

“We support the work of AAHRPPbecause we share their dedication tothe highest standards for research andbecause AAHRPP is the organizationthat is seeking to resolve these issuesthrough a voluntary set of solutions,”Mr. Devereux says.

AAHRPP currently has 11 Support-ing Members that encourage thoseengaged in human research to attainaccreditation to help ensure the welfareand safety of research participants.

Newest Supporting Member Represents Social Science Research

4 AAHRPP ADVANCE

Even before they achieved AAHRPPaccreditation, UI and WIRB were inthe forefront of the accreditationmovement. Both organizations hadparticipated in the debate on the needfor greater accountability in humanresearch and recognized that accredi-tation had a critical role to play.

“We were longtime advocates of anaccreditation process,” explainsAngela Bowen, M.D., founder andPresident of WIRB. “Since we hadbeen in favor of accreditation andhad promoted it for so many years,we would have been remiss if we had-n’t been among the first to apply.”

Both WIRB and UI had longadhered to the principles of accredita-tion, committing to continuous quali-ty improvement and setting humanresearch protections as the top prioritythroughout their organizations.

“We’d been following the discus-sion for a number of years and hadbeen making changes as needed,”says David Wynes, Ph.D., UI SeniorAssociate Vice President for Research.“If we hadn’t already been engaged incontinuous quality improvement, wecouldn’t have been among the first toapply and succeed.”

Other institutions have followedtheir lead, and, within the next sever-al years, most major U.S. researchorganizations are expected to com-

plete the accreditation process. By then, reaccreditation will be in full swing.

For both, the decision to seekaccreditation was motivated, in part,by the desire to make a statementabout the future of the research enter-prise. “One of our major activities is tosupport other research institutionsand provide IRB services,” Dr. Bowensays. “We knew that many of themintended to seek accreditation, and wefelt it might help smooth the way ifwe attained accreditation up front.”

WIRB is known worldwide for itseducation in support of ethicalresearch. WIRB operates an interna-tional Fellows program with the WorldHealth Organization and providestraining in IRB/Ethics Committeeadministration. In the United States,WIRB conducts training for researchsupport staff and IRB members.

In UI’s case, pursuing accreditationalso reflected the university’s convic-tion that the research enterprise iscapable of monitoring itself. “Webelieve that research institutions canoperate ethically and can self-gov-ern,” Dr. Wynes says. “Accreditationhelps make that statement.”

Even more important, however, arethe tools that accreditation provides tohelp organizations govern themselvesand fulfill their obligations to research

participants. Chief among these toolsare the rigorous self-assessment andthe site visits that provide objective,professional evaluations of the accred-itation candidates’ human researchprotection programs (HRPPs).

The self-assessment requiresaccreditation candidates to take acritical, detailed look at their poli-cies and procedures, and to meas-ure their research protection effortsagainst AAHRPP’s 20 standards and77 elements. During the self-assess-ment, HRPPs typically undergo themost change. Some actually experi-ence a cultural shift, as every indi-vidual within the organizationcomes to terms with his or her per-sonal responsibility for safeguard-ing research participants.

“The accreditation process willmake virtually every research pro-gram better, especially if you’re honestwith yourself during the self-assess-ment and respond by making the nec-essary adjustments,” Dr. Bowen says.

Dr. Wynes agrees. “The bulk of thework is done through the self-assess-ment,” he says. He also emphasizesthe value of the site visit, which “givesyou access to a team of people whohave enormous breadth and depth ofexperience and who will review yourprogram in a very confidential way.”

Since UI earned accreditation, Dr.Wynes has assumed an increasinglyimportant role in the accreditationmovement, as a site visitor forAAHRPP, a member of AAHRPP’sCouncil on Accreditation, and now, as Council Chair.

“I believe in accreditation and itspotential to benefit the research enter-prise and those we are responsible toprotect,” Dr. Wynes says. “Increasingly,organizations are realizing thataccreditation is an indicator of a quality program.”

UI and WIRB Set Example for Accreditation

On April 28, 2003, the University of Iowa (UI) and Western Institutional

Review Board (WIRB) became the first organizaton to earn AAHRPP

accreditation. Because of their standing within the research community —

UI currently has approximately 2,500 active human research protocols, and

WIRB provides IRB services to approximately 150 institutions — their deci-

sion to seek accreditation bolstered the status of AAHRPP and the accredita-

tion movement. It also delivered a resounding message about their support

for accreditation, their confidence in the quality of their research programs,

and their fundamental commitment to human research protections.

AAHRPP ADVANCE 5

REESE T. JONES, M.D.

Insights into IRBsComplaints from research participants or their family members require a

thoughtful response that addresses the specifics of the complaint, demonstrates

the IRB’s sensitivity to the often vulnerable position of research participants and,

above all, reflects the IRB’s responsibility to help ensure participants’ protection.

In the Questions and Answers below, Reese T. Jones, M.D., shares his experience

in addressing complaints during more than three decades as an investigator

and IRB member at the University of California, San Francisco (UCSF). A profes-

sor of psychiatry, Dr. Jones also is Chairperson of the Committee on Human

Research, which is one of four UCSF IRBs.

Q. What types of complaintshave you received over theyears?

A. I’ve heard almost every type ofcomplaint you can imagine, partlybecause of my long tenure and partlybecause we have over 3,000 activeprotocols at any given time. The num-ber of complaints is actually verysmall compared to the number of protocols and participants involved.

Complaints run the gamut fromfinancial concerns to privacy issues tocomplaints about the way theresearch is being done — that it devi-ates from procedures described in theinformed consent document, fromwhat the participant expected, oreven, from the way the investigatorsanticipated. Financial complaintsmay come from subjects who arebeing paid to participate and whosepayments have been delayed. Or they may involve a participant whoexpects medical expenses to be cov-ered because of his or her participa-tion in research but receives a sizablebill from a medical establishment.Some of the most heart rending com-plaints are from patients who wantdesperately to be included in a study— who believe it may be their onlyhope for survival — but are excludedbecause they don’t meet the studyentry criteria. And of course, the mosttroubling complaints, and those that

require immediate action, are theones that involve an allegation orappearance of an event that resultedin harm to the research participant.

Q. How should investigators andIRBs handle complaints?

A. The organization and the IRBshould have standard operating pro-cedures describing how to handle acomplaint, starting with determining,as rapidly as possible, how serious itmight be. There should be written andreadily available guidelines on how

complaints are handled, includingprocesses for complaints involving sci-entific or other misconduct or the riskof harm to participants. There alsoshould be a written record of whathappened. The detail would depend,of course, on the nature of the com-plaint and its resolution. All of this isin keeping with best IRB practices andwith accreditation standards.

Standard procedures are importantbecause they lay out the process and

make sure that each complaint isaddressed in a systematic, fair, andjust way. But what’s just as importantis how we treat the individual makingthe complaint. Those of us who serveon the IRB are here primarily to pro-tect the interests of the research partic-ipant, not the institution or the inves-tigators — and our response to eachcomplaint should reflect that responsi-bility and priority. Our responseshould acknowledge that each com-plainant is a human being, deservinga fair hearing and some empathy.

One of the best ways to demonstratethat empathy is to make it clear to theresearch participant that each com-plaint is taken seriously. I start, forexample, by calling the complainantas soon as possible, instead of waitingand sending a formal letter. At UCSF,we are often able to resolve an issuewithin a few hours. Prompt attentiondelivers the message that we’re con-cerned and responsive. This is true

CONTINUED ON PAGE 6

“Those of us who serve on the IRB are here primarily to

protect the interests of the research participant, not the

institution or the investigators — and our response to each

complaint should reflect that responsibility and priority.”

6 AAHRPP ADVANCE

even in those instances in which acomplaint stems from the nature ofthe research process itself rather thanthe actions of a particular investigatoror the requirements of a particularexperiment. The phone call establish-es a personal connection, perhapsparticularly if it comes from an IRBchair. It assures the complainant thatwe appreciate his or her role in theresearch, that his or her concerns arevalid, and that we will make the timeto adequately address them.

It’s important to remember,though, that a rapid response doesnot mean a sloppy response. The bestapproach is a combination of person-al attention, documentation, and fol-low-through.

Q. What should an IRB or inves-tigator not do in response toa complaint?

A. I avoid the temptation to respondvia e-mail, even when that’s the waythe complaint was delivered. Brief andhasty e-mails can too easily be mis-construed, resulting in needless mis-understanding. Any written docu-ments should be carefully written. If a complaint comes in via e-mail andthe individual did not include aphone number, respond by asking forone. Then, pick up the phone andmake the personal contact.

Everyone who complains has madea deliberate decision to do so. Theybelieve they have a valid reason. Thatalone is worthy of our time and atten-tion. Based on my own experience, Ibelieve one may be pleasantly sur-prised at what transpires during thosephone calls. I come away from mostof them feeling that, in a very smallway, I’ve made a difference in the per-son’s life simply by taking their con-cerns seriously.

Q. Do you think individuals aremore or less willing to partici-pate in research today? Why?

A. Certainly, our IRB encounters pro-tocols where investigators appear tofind it harder to recruit subjects. Butwe have to keep in mind that clinicalresearchers are conducting manymore studies than in the past, so mostlikely overall we are enrolling manymore participants. Without a doubt,those research subjects who do partici-pate are more knowledgeable. They

read newspaper articles aboutresearch, and they inquire about pro-tections. Yes, that places a greater bur-den on the IRB and on investigatorsto explain exactly what the experi-ment entails. Quite possibly, it evenresults in more complaints. Duringmy own 40 years of human laborato-ry research, I can’t think of a seriouscomplaint from a truly informed par-ticipant. Most complaints from mysubjects have been the result of mis-understandings or miscommunica-tion. In so many ways, today’sresearch participants have a betterunderstanding of the risks of researchand perhaps even a greater apprecia-tion of its potential benefits.

Q. Do you think educating thepublic would help or hinderparticipants’ view ofresearch?

A. I think that educating the publicwill help achieve a more realistic viewof research procedures and processes.In the short term, that might make it

harder to recruit subjects. But as thepublic becomes more aware of howthe process works and of the safe-guards — such as accreditation —that are available, we could see lessreluctance to participate. I believe thateach interaction with a research par-ticipant, even if only concerned withresolving a complaint, provides anopportunity for education. Theinformed consent process, for exam-ple, should involve an adequate verbal exchange during whichresearchers educate the subject about

the details of a particular protocol aswell as teach them something aboutthe research process in general.

I see a difference each time I spenda few extra minutes listening to con-cerns and then explaining somethingto a complainant. Quite often, myresponse isn’t exactly what they want-ed to hear. Instead, it might involvean explanation of randomization, theimportance of inclusion and exclusioncriteria, the scientific method, andwhy an experiment has to be con-ducted in a particular way. More oftenthan not, the aggrieved subject goesaway understanding more aboutresearch and more likely to partici-pate again in the future, so the littleextra effort expended comes back tohelp us as well. At UCSF, complaintsare few, I believe as a direct conse-quence of a diligent IRB review andeducation process and responsiveresearchers who care for their researchsubjects. The extra effort IRB chairsdevote to dealing with subject com-plaints is not a great burden.

“In so many ways, today’s research participants have a

better understanding of the risks of research and perhaps

even a greater appreciation of its potential benefits.”

Insights into IRBs FROM PAGE 5

1. Category 11.1. The research is conducted in

established or commonly acceptededucational settings.

1.2. The research involves normal educational practices, such as:1.2.1. Research on regular and

special education instructionalstrategies.

1.2.2. Research on the effectiveness of or the comparison amonginstructional techniques, curricula, or classroom management methods.

1.3. The research does not involve prisoners as participants.

1.4. The research is not FDA-regulated.

2. Category 22.1. The research involved the use of

one or more of the following:2.1.1. Educational tests (cognitive,

diagnostic, aptitude, achievement).

2.1.2. Survey procedures.2.1.3. Interview procedures.2.1.4. Observation of public

behavior.2.2. If any disclosure of the participants’

responses outside the research couldreasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.2.2.1. Information obtained is not

recorded in such a manner thatparticipants can be identified,directly or indirectly through identi-fiers linked to the participants.

2.3. If the research is VA-regulated,2.3.1. If any disclosure of the

participants’ responses outsidethe research could reasonablyplace the participants at risk of loss of insurability.2.3.1.1. Information obtained

is not recorded in such amanner that humanparticipants can beidentified, directly orthrough identifierslinked to the partici-pants.

2.4. If the research involves children as participants:2.4.1. The procedures do not involve

any of the following:2.4.1.1. Survey procedures.2.4.1.2. Interview procedures.2.4.1.3. Observation of public

behavior where theinvestigators participatein the activities beingobserved.

2.5. The research does not involve prisoners as participants.

2.6. The research is not FDA-regulated.

3. Category 33.1. The research is not exempt under

Category 2.3.2. Research involving the use of one

or more of the following:3.2.1. Educational tests (cognitive,

diagnostic, aptitude, achievement).

3.2.2. Survey procedures.3.2.3. Interview procedures.3.2.4. Observation of public behavior.

3.3. Either of the following is true:3.3.1. The participants are elected

or appointed public officials orcandidates for public office.

3.3.2. Federal statute(s) require(s)without exception that the confidentiality of the personallyidentifiable information will bemaintained throughout theresearch and thereafter.

3.4. The research does not involve prisoners as participants.

3.5. The research is not FDA-regulated.

4. Category 44.1. The research involving the collection

or study of existing data, documents,records, pathological specimens, ordiagnostic specimens.

4.2. Either of the following is true:4.2.1. The sources are publicly

available.4.2.2. The investigator records infor-

mation in such a manner thatparticipants cannot be identi-fied, directly or indirectlythrough identifiers linked to theparticipants.

4.3. The research does not involve prisoners as participants.

4.4. The research is not FDA-regulated.

5. Category 55.1. The project is a research or

demonstration project.5.2. The research is conducted by or

subject to the approval of federalDepartment or Agency heads.

5.3. The research is designed to study, evaluate, or otherwise examine one or more of the following:5.3.1. Public benefit or service

programs.5.3.2. Procedures for obtaining

benefits or services under thoseprograms.

5.3.3. Possible changes in or alterna-tives to those programs or procedures.

5.3.4. Possible changes in methods orlevels of payment for benefits orservices under those programs.

5.4. The program under study delivers a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutritionservices as provided under the Older Americans Act).

5.5. The research is conducted pursuant to specific federal statutory authority.

5.6. There is no statutory requirement that an IRB review the research.

5.7. The research does not involve signifi-cant physical invasions or intrusionsupon the privacy of participants.

5.8. The research does not involve prisoners as participants.

5.9. The research is not FDA-regulated.

6. Category 66.1. The research involves taste and food

quality evaluation or is a consumeracceptance study.

6.2. Either of the following is true:6.2.1. Wholesome foods without

additives are consumed.6.2.2. If a food is consumed that

contains a food ingredient or an agricultural chemical orenvironmental contaminant, thefood ingredient or agriculturalchemical or environmental contaminant is at or below thelevel and for a use found to besafe by one of the following:6.2.2.1. The Food and Drug

Administration.6.2.2.2. The Environmental

Protection Agency.6.2.2.3. The Food Safety and

Inspection Service ofthe U.S. Department of Agriculture.

6.3. The research does not involve prisoners as participants.

AAHRPP ADVANCE 7

Institutions are allowed to exempt cer-tain types of research from the federalregulations, but determining whethera protocol meets exemption criteria isno easy task. To qualify, the researchmust fulfill more than 35 requirementsestablished by two different federalagencies: the Department of Healthand Human Services (DHHS) and theFood and Drug Administration (FDA).

Although most investigators andIRB members are familiar with theDHHS exemption criteria, many donot realize that FDA regulations alsoapply. Even those who are aware ofboth sets of regulations find them diffi-cult to compare and reconcile, in partbecause there has been no singlesource of information on the criteria — until now.

Navigating the Regulations for Research Exemptions

Criteria Allowing Exemption from Federal Regulations

Registration is open for the 2007AAHRPP Conference: QualityHuman Research ProtectionPrograms, which will be held February25-27 in Baltimore, Maryland. Theconference is geared to individualsfrom both accredited and non-accredit-ed organizations, including thoseworking on accreditation or those whoare new to the accreditation process. Itis also targeted to stakeholders — gov-ernment, industry, voluntary healthagencies, and community groups —that are concerned with promotinghuman research protection and quali-ty research. Institutional officials, IRBprofessionals and chairs, complianceprofessionals, researchers, sponsors,and patient group leaders shouldattend.

The session begins with pre-confer-

ence workshops on Sunday, February25, 2007, followed by the conferenceMonday, February 26 and Tuesday,February 27, 2007. For more informa-tion or to register online, visitwww.aahrpp.org.

Helpful Information Online

2007 Fee Schedule: Application and annual fees for 2007are available at www.aahrpp.org.

Submission Deadlines: Submission dates for new and re-newing applicants are posted atwww.aahrpp.org. In general, for new applicants, materials are dueseven months prior to Council onAccreditation meetings. Renewingapplications are due at least ninemonths prior to Council meetings.

Accreditation Workshops

These workshops are designed for indi-viduals who are conducting a self-assessment or preparing the accredita-tion application. The day-long sessionsprovide helpful information on navi-gating the accreditation process, lead-ing the self-assessment, preparing theapplication, and making effective useof the AAHRPP Evaluation Instrumentfor Site Visitors. They discuss the mostcommon challenges that organizationsface in meeting accreditation stan-dards, and they provide ample oppor-tunity to interact one-on-one withAAHRPP staff to discuss concerns specific to each organization.

AAHRPP ADVANCEis published quarterly by the Associationfor the Accreditation of Human ResearchProtection Programs, Inc.

Executive Director:Marjorie A. Speers, Ph.D.

Editor:Elisa GallaroClifton Park, NY

Design: Levine & Associates, Inc.Washington, DC

Printing: Federation of American Societiesfor Experimental Biology (FASEB)

Non-Profit Org.U.S. Postage

P A I DWashington, DCPermit No. 96

Conference Registration Underway

Workshop schedule

■ Friday, January 26■ Friday, March 30■ Thursday, May 24

Workshops are conducted from 9a.m. to 4 p.m. at AAHRPP; lunchis provided.